Philips M3860A User manual

POWER TO SAVE A LIFE

M3860A, M3861A

Edition 10

HEARTSTART FR2+ DEFIBRILLATOR

INSTRUCTIONS FOR USE

Philips Medical Systems

The HeartStart FR2+ Defibrillator

Clockwise from top right.

Battery. Standard long-life or

rechargeable battery used to power the

FR2+. (Check local regulations for

disposal and recycling requirements.)

On/Off button. Turns on the

FR2+ and starts voice and screen

prompts. Second press turns off the

FR2+.

Status Indicator. Shows you the

readiness status of the FR2+.

Display screen. Displays text

prompts and incident data. The FR2+

M3860A screen also displays the

patient’s ECG.

Option buttons. Adjust the

contrast of the screen display and

control special functions.

Beeper port. Broadcasts alert

beeps when required. It is located under

the right edge of the FR2+.

Infrared (IR) communications

port. A special lens, or “eye,” used to

transfer data directly to or from another

device.

Data card port. Receptacle for

data card tray.

Data card (optional). Used to

store and review information about an

incident, including ECG and optional

voice recording.

Data card tray. Special sleeve that

holds the data card and fits into the data

card port to help seal the FR2+ against

fluids. The tray should be kept installed

in the FR2+ even if no data card is

used.

Microphone. Used optionally to

record surrounding audio during an

incident. It is located under the right

edge of the FR2+.

Shock button. Controls shock

delivery. The button flashes when the

HeartStart FR2+ is ready to deliver a

shock.

Speaker. Amplifies voice prompts

during use of the FR2+.

Pads placement diagram.

Illustrates correct placement of pads.

Diagrams are also shown on the

defibrillator pads.

Defibrillator pads connector

socket. Receptacle for connector of the

defibrillator pads cable. An adjacent LED

light flashes to show socket location and

is covered when connector is inserted.

Adult defibrillator pads. Self-

adhesive pads with attached cable and

connector.

A

B

C

D

E

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H

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Philips Medical Systems

HEARTSTART FR2+ DEFIBRILLATOR

QUICK REFERENCE CARD

Philips Medical Systems

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Philips Medical Systems

HEARTSTART FR2+

M3860A, M3861A Defibrillator

INSTRUCTIONS FOR USE

Edition 10

Philips Medical Systems

M3860A/M3861A HEARTSTART FR2+

Instructions for Use

Equipment specifications are subject to alteration

without notice. All changes will be in compliance

with regulations governing manufacture of

medical equipment.

Printed in the U.S.A.

Publication date: August 2003

Publication number: M3860-91900

Part number: 011120-0010

No part of this publication may be reproduced,

transmitted, transcribed, stored in a retrieval

system or translated into any human or computer

language in any form by any means without the

consent of the copyright holder.

Unauthorized copying of this publication may not

only infringe copyright but also reduce the ability

of Philips Medical Systems to provide accurate

and up-to-date information to users and operators

alike.

Philips Medical Systems reserves the right to

make changes in specifications or to discontinue

any product at any time without notice or

obligation and will not be liable for any

consequences resulting from the use of this

publication.

Authorized EU Representative

Philips Medizinsysteme Boeblingen GmbH

Hewlett-Packard Strasse 2

71034 Boeblingen, Germany

(+49) 7031-14-5151

CAUTION

FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE

BY OR ON THE ORDER OF A PHYSICIAN.

The HeartStart FR2+ is designed to be used only with Philips-

approved accessories. The HeartStart FR2+ may perform

improperly if non-approved accessories are used.

Device Tracking

In the U.S.A., this device is subject to tracking requirements by

the manufacturer and distributors. If the defibrillator has been

sold, donated, lost, stolen, exported, or destroyed, notify Philips

Medical Systems or your distributor.

Device Manufacturer

The HeartStart FR2+ Defibrillator is manufactured by Philips

Medical Systems, Seattle, Washington, USA.

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Philips Medical Systems

Contents

1 Introduction to the HeartStart FR2+

What is the HeartStart FR2+? ................................................................. 1-1

When Is the HeartStart FR2+ Used? .................................................... 1-2

How Does the HeartStart FR2+ Work? ................................................ 1-2

How Is the HeartStart FR2+ Supplied? ................................................ 1-3

2 Preparing Your HeartStart FR2+ for Use

Overview ....................................................................................................... 2-1

Installing the Battery ................................................................................... 2-1

Setting the Clock ........................................................................................ 2-3

Running the Battery Insertion Selftest .................................................... 2-4

Placing and Securing the HeartStart FR2+ .......................................... 2-5

3 Using Your HeartStart FR2+

Overview ....................................................................................................... 3-1

Step 1: Preparation .................................................................................... 3-2

Step 2: ECG Analysis and Monitoring ................................................... 3-3

Step 3: Shock Delivery .............................................................................. 3-4

ECG Display for Ongoing Observation ................................................. 3-5

4 Maintaining, Testing, and Troubleshooting

Your HeartStart FR2+

Overview ....................................................................................................... 4-1

Maintenance ................................................................................................. 4-1

After Using the HeartStart FR2+ ............................................................. 4-2

Cleaning the HeartStart FR2+ ......................................................... 4-3

Operator’s checklist ............................................................................ 4-3

Testing ........................................................................................................... 4-5

Battery insertion selftest .................................................................... 4-5

Periodic selftests ................................................................................. 4-9

Device history ....................................................................................... 4-9

Battery History ..................................................................................... 4-10

Troubleshooting Guide .............................................................................. 4-11

Status indicator summary .................................................................. 4-11

Recommended action during an emergency ................................ 4-11

Troubleshooting during patient use ................................................ 4-12

General troubleshooting .................................................................... 4-14

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M3860A/M3861A HEARTSTART FR2+

5 Clinical and Safety Considerations

Clinical Considerations .............................................................................. 5-1

Indications ............................................................................................. 5-1

Contraindications ................................................................................ 5-1

Safety Considerations ................................................................................ 5-1

General dangers, warnings, and cautions ..................................... 5-2

Defibrillation warnings and cautions ............................................... 5-4

Monitoring cautions ............................................................................ 5-5

Maintenance cautions ........................................................................ 5-5

6 Setup and Advanced Mode Features

Setup Overview ........................................................................................... 6-1

Non-protocol parameters .................................................................. 6-1

Automatic protocol parameters ....................................................... 6-2

Manual override parameters ............................................................. 6-4

Using Setup Features ........................................................................ 6-5

Reviewing current setup .................................................................... 6-6

Revising setup ...................................................................................... 6-6

Receiving setup ................................................................................... 6-7

Reading setup ...................................................................................... 6-8

Sending and Receiving Clock Settings ................................................. 6-8

Using Advanced Mode Features ............................................................. 6-9

Using the manual analyze feature .................................................... 6-10

Using the manual charge feature (M3860A only) ........................ 6-11

7 Data Management and Review

Overview ....................................................................................................... 7-1

Recording Incident Data ............................................................................ 7-1

Recording data in internal memory ................................................. 7-1

Recording data on a data card ........................................................ 7-1

Reviewing Incident Data ............................................................................ 7-3

Reviewing data from internal memory ............................................ 7-3

Reviewing data from a data card ..................................................... 7-4

Contents

Philips Medical Systems

Appendices

3

A Accessories for the HeartStart FR2+

HeartStart Accessories ............................................................................. A-1

Suggested Additional Items ..................................................................... A-2

B Technical Specifications

HeartStart FR2+ Defibrillator Specifications ........................................ B-1

Accessories Specifications ...................................................................... B-6

C Glossary of Symbols and Controls

Instructions for Use ..................................................................................... C-1

HeartStart FR2+ M3860A and M3861A Defibrillator

Symbols and Controls ................................................................................ C-1

Accessories Symbols ................................................................................. C-3

D Glossary of Terms

Index

M3860A/M3861A HEARTSTART FR2+

Philips Medical Systems

Notes

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1

1 Introduction to the HeartStart FR2+

What is the HeartStart FR2+?

The HeartStart FR2+ Defibrillator (“FR2+”) is an automated external

defibrillator. It is compact, lightweight, portable, and battery powered. It is

designed for simple and reliable operation by a trained responder.

NOTE: The HeartStart FR2+ is an enhanced version of the defibrillator

previously sold as the Heartstream FR2. The FR2+ has all the features of the

FR2. All accessories compatible with the FR2 are also compatible with the

FR2+. However, the FR2+ has some new features not present in the FR2

and can be used with certain accessories (labeled FR2+) that are not

compatible with the FR2.

The FR2+ has a Status Indicator that is always active, so you can tell at a

glance if it is ready for use. The front panel of the FR2+ has an On/Off button

at the top and a Shock button at the bottom. A display screen in the center of

the panel provides text prompts and incident information. Voice prompts are

provided through a speaker located at the base of the FR2+. (See the

diagram on the inside front cover for details.)

The FR2+ is available in two models, the M3860A and the M3861A. They

share a set of basic features, detailed in Chapter 6. The principle differences

between the two models are identified below:

NOTE: The FR2+ comes with a factory default setup that can be modified.

(See Chapter 6, “Setup and Advanced Mode Features,” for a description of

setup defaults and options.)

model M3860A model M3861A

Configurable ECG display on screen Text prompt display on screen, no ECG

display

Configurable manual charge in

advanced mode

No manual charge in advanced mode

M3860A/M3861A HEARTSTART FR2+

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When Is the HeartStart FR2+ Used?

The HeartStart FR2+ Defibrillator is used with disposable defibrillator pads

applied to a person who is experiencing the symptoms of sudden cardiac

arrest (SCA): lack of responsiveness and lack of breathing. Defibrillation

should not be performed on anyone who is responsive or is breathing.

Infant/child reduced-energy defibrillator pads are available for use with the

FR2+ on children under the age of 8 or weighing less than 55 pounds (25

kg).

The FR2+ is intended for use by emergency care personnel who have been

specifically trained in the operation of the FR2+ or who are qualified by

training in Basic Life Support (BLS), in Advanced Life Support (ALS), or in

other physician-authorized emergency medical response.

At the discretion of emergency care personnel, the M3860A FR2+ with

ECG display enabled can also be used with the FR2+ ECG assessment

module to display the rhythm of a responsive or breathing patient, regardless

of age. The FR2+ Defibrillator used with the FR2+ ECG assessment module

provides a non-diagnostic display for attended patient monitoring. While

connected to the FR2+ ECG assessment module, the FR2+ displays and

evaluates the patient's ECG and disables its shock capability.

How Does the HeartStart FR2+ Work?

The HeartStart FR2+ Defibrillator is designed to provide external

defibrillation therapy to someone in cardiac arrest. Defibrillation therapy is

the best available way to treat a variety of potentially fatal heart arrhythmias.

The FR2+ is extremely easy to use. When connected to defibrillator pads

that are properly applied to the patient’s bare chest, the FR2+:

1. prompts you to take specific actions,

2. automatically analyzes the patient's heart rhythm and advises you

whether or not the rhythm is shockable, and

3. arms the Shock button, if appropriate, and instructs you to press it to

deliver a biphasic electric pulse designed to defibrillate the heart.

Detailed instructions for use are provided in Chapter 3.

Introduction to the HeartStart FR2+

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1

How Is the HeartStart FR2+ Supplied?

The HeartStart FR2+ Defibrillator is supplied with a standard long-life

battery, two sets of adult defibrillator pads with integrated cable and

connector, and a data card tray. Other accessories, including an FR2+

rechargeable battery, FR2 infant/child reduced-energy defibrillator pads, and

(for M3860A only, with ECG display enabled) a three-wire FR2+ ECG

assessment module, are available. See Appendix A for a list of accessories

and other recommended supplies.

Philips Medical Systems

M3860A/M3861A HEARTSTART FR2+

Notes

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2 Preparing Your HeartStart FR2+ for

Use

Overview

There are a few basic steps to preparing your HeartStart FR2+ Defibrillator

for use:

 Install data card (optional).

 Install a battery.

 Set the clock in the FR2+ (optional).

 Run the battery insertion selftest.

 Place the FR2+ with recommended accessories in a convenient

location.

The instructions presented here briefly describe the normal sequence of

preparation. It assumes that you are using a fresh battery, that the selftest

passes, that you are not using a data card, and that the factory default

settings will not be changed. Exceptions to this sequence are provided

elsewhere in this manual.

Installing the Battery

The HeartStart FR2+ Defibrillator is shipped with a M3863A standard,

long-life battery. The battery is enclosed in a gray plastic case. There is a

yellow latch at one end that holds the battery in place when it is correctly

installed in the FR2+. (The optional M3848A FR2+ rechargeable battery is

enclosed in a blue plastic case and also has a yellow latch. Except where

otherwise noted, the following information applies to both battery types.)

Before installing the battery, make sure the defibrillator pads are not

connected to the FR2+. To install the battery:

1. Hold the battery by the latch end and slide it into the battery

compartment at the top of the FR2+.

2. Slide the battery all the way into the opening, until the latch clicks into

place. The latch will click into place only when the battery is inserted

correctly.

CAUTION: Follow all instructions supplied with the HeartStart M3863A

standard battery. Install the battery before the install-by date shown on the

battery.

M3860A/M3861A HEARTSTART FR2+

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When the battery is installed, the FR2+ automatically turns on. The Status

Indicator displays a flashing black hourglass. The Shock button light and the

indicator light for the defibrillator pads connector socket turn on briefly.

The display screen brings up the main menu. From this menu, you can start

the FR2+ battery insertion selftest, review information from the last time the

FR2+ was used, or go to the next screen for other options. Information about

the optional data card and the battery status is also provided. (See Chapter

7, “Data Management and Review,” for details about reviewing an incident

and using a data card.) For the M3863A standard battery, a

GOOD BATTERY

message should be displayed. For the M3848A FR2+ rechargeable battery,

a “fuel gauge” graphic illustrates remaining power. Throughout the remainder

of this manual, the screen displays illustrated will be for the standard battery

unless otherwise noted.

NOTE: This screen will not be displayed if the FR2+ is connected to

defibrillator pads (that are applied to the patient) when the battery is inserted,

and you will not be able to access the menu items. In addition, the battery

insertion selftest and periodic automatic selftests cannot run while the

defibrillator pads are connected to the patient. Be sure to unplug the pads

connector from the FR2+ after each use. Do not store the FR2+ with the

pads connected.

NOTE: To move around the menus displayed, use the Option buttons as

follows:

• Press the

LOWER Option button to move the highlight bar from one

item to another on the menu.

• Press the

UPPER Option button to select the highlighted item or to

scroll through the settings for that item.

If you select

NEXT, the menu displayed lets you review the history of the

FR2+, review the history of the battery being used, access setup data, set

the clock, or return to the first menu. (See Chapter 4, “Maintaining, Testing,

and Troubleshooting Your HeartStart FR2+,” for details about the review

options and Chapter 6, “Setup and Advanced Mode Features,” for

information on the setup option.)

Preparing Your HeartStart FR2+ for Use

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NOTE: If you make no selection for 10 seconds, the selftest will

automatically run. If you want to select something different from either of

these menus, you must do so before the selftest begins, or remove and

reinstall the battery to bring up the main menu. You can press the On/Off

button at any time to turn off the FR2+ and return it to standby (ready for

use) mode. To use the FR2+, press the On/Off button again.

Setting the Clock

It is recommended that the first time you prepare your HeartStart FR2+

Defibrillator for use, you check the FR2+’s internal clock to be sure it is set to

the correct date and local time. You can reset it if necessary.

To see the clock settings, select

NEXT from the first menu, within 10 seconds

of installing the battery, and then select

CLOCK. To do this:

1. Press the lower Option button to move the highlight bar to

NEXT.

2. Press the upper Option button to bring up the

NEXT screen.

3. Press the lower Option button to move the highlight bar to

CLOCK.

4. Press the upper Option button to bring up the

CLOCK screen.

The

CLOCK screen displays the date and time currently set in the internal

clock of the FR2+.

NOTE: The date is displayed as day (DD), month (MM), and year (YY), as

shown on the screen. The time is displayed using the 24-hour international

clock.

If no changes to the clock settings are needed, select

RETURN and go back

to the first menu. If the date and time are not correct, there are two ways to

set them:

 Receive the clock settings from another FR2+ or from a computer using

HeartStart Event Review® software,

*

using the RECEIVE TIME option.

This may be used to synchronize the clocks of several FR2+s. You can

also send the clock settings from one FR2+ to another one, using the

SEND TIME option. See Chapter 6, “Setup and Advanced Mode

Features,” for instructions.

 Manually set the date and the time.

* HeartStart Event Review software was previously sold as CodeRunner software.

M3860A/M3861A HEARTSTART FR2+

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To manually set the clock:

1. Use the lower Option button to move the highlight bar to the part of the

clock setting you want to change.

2. Press the upper Option button repeatedly to scroll through the settings

until you reach the one you want. If you go past it, keep scrolling until it

comes up again.

3. Use the lower Option button to select the next part you want to change,

and repeat the process, until all parts of the date and time have been set.

4. When you have made all the changes, move the highlight bar to

RETURN

and press the upper Option button to go back to the main menu screen.

NOTE: New clock settings are used by the FR2+ as soon as you set them.

The clock time display is updated each minute this screen is displayed. The

clock seconds, although not displayed, are set to 00 when you move the

highlight bar out of the time settings.

NOTE: If the battery is removed from the FR2+ for more than two hours, the

clock settings will be lost and must be reset.

Running the Battery Insertion Selftest

Except in an emergency, it is recommended that you run this selftest every

time you change the battery. Make sure the defibrillator pads are not

connected to the HeartStart FR2+ Defibrillator before running the battery

insertion selftest.

The selftest has two parts. The first part automatically tests the FR2+

circuitry. The second part is interactive and requires you to respond to

prompts in order to make sure the display, buttons, lights, speaker, and

beeper of the FR2+ are working properly. (See Chapter 4, “Maintaining,

Testing, and Troubleshooting Your HeartStart FR2+,” for details about this

selftest.)

To run the selftest:

1. Make sure the defibrillator pads are not connected to the device.

2. Insert the battery into the battery port. The first screen displayed has

RUN SELFTEST highlighted.

Preparing Your HeartStart FR2+ for Use

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2

3. Press the upper Option button to activate the test.

4.

OR make no selection for 10 seconds, and the selftest will start

automatically if the FR2+ has been turned off for at least 5 minutes.

NOTE: If you connect defibrillator pads (that are applied to the patient) to

the FR2+ during a battery insertion selftest, the selftest will stop and the

FR2+ will go to its standby mode to be ready for use.

When the automatic part of the selftest is successfully completed, the screen

displays a message that the test has passed, and then automatically starts

the interactive part of the selftest. It is important to press the buttons and

verify the indicators to ensure that the FR2+ will be ready for use.

When the entire selftest is complete, the FR2+ automatically turns off and

returns to standby mode. In the standby mode, the Status Indicator displays

a flashing black hourglass. This means that the FR2+ has passed its most

recent self-test and is therefore ready for use, simply by pressing the On/Off

button to turn it on.

Placing and Securing the HeartStart FR2+

Place the HeartStart FR2+ Defibrillator in an accessible area with the Status

Indicator easily visible. Useful accessories for placing and securing the FR2+

include a carrying case, which is suitable for use with a wall mount bracket or

defibrillator cabinet. (See Appendix A for a list of accessories.)

NOTE: Do not store the FR2+ with the defibrillator pads attached. Do not

open the pads package until ready for use.

With the battery installed and the FR2+ stored in appropriate environmental

conditions, the FR2+ performs detailed periodic selftests to make sure that it

remains ready for use. (See Appendix B for the environmental storage

specifications.)

While the FR2+ is in the standby mode, the Status Indicator shows the

flashing black hourglass unless the periodic selftests detect a problem. If a

problem is detected, the Status Indicator will show a flashing red X or a solid

red X and the FR2+ will beep (“chirp”) to alert you to the need for

troubleshooting. (See Chapter 4, “Maintaining, Testing, and Troubleshooting

Your HeartStart FR2+,” for instructions.)

GOOD BATTERY

Philips Medical Systems

M3860A/M3861A HEARTSTART FR2+

Notes

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